Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know. 

We recently attended a workshop sponsored by DNV, a leading certification body titled “Updates and Impacts.” An agenda item for the workshop that spiked our interest was AS9100C Lessons Learned and Updates.

The following is information we noted and want to share with our AS9100C Aviation, Space and Defense clients and newsletter readers.

(1) If your organization is not certified to AS9100C by the July 1, 2012 deadline, you can be given an additional six months to 1/4/13 to be certified. However, your organization will be put on “Suspension” status. If you do not become certified by the extended date your certification will be withdrawn.

(2) CB audit results are showing a ”Failure to follow a Process Approach.”  Examples given:

• Processes comprising the QMS not identified

• Process owners not assigned

• Interaction and interfaces of processes not defined

• Process effectiveness unknown (too often doing only manufacturing processes – what about purchasing, sales, design and development)?

• Process improvement not emphasized

• PEAR forms compromised (CB auditors are responsible for completing PEARs.)

(3) Customers can e-mail a CB through OASIS of supplier problems. A customer complaint can drive a “special audit” where the supplier may be charged by the CB for its special audit conducted.

(4) You must inform your customer of a “work transfer.” For example, moving your production line to another location – e.g., Mexico.

(5) A customer can request to see a suppliers CB audit results through OASIS.

(6) Reductions of observations are being cited due to no more “soft grading.”

(7) If a similar nonconformance is found in two consecutive audits, a major nonconformance will be written (this can be as simple as two document control issues found).

(8) ”There are still CB auditors out there doing inconsistencies regarding application and interpretation of the AS9100C requirements.” For example, telling clients that a risk management process/file must be documented for all products produced.   All AS9100C CB auditors took the same four day course and was provided the same material. However, interpretation of the new AS9100C requirements was Not part of the training. 

(9) If you believe your CB auditor is wrong from a standard requirement or business perspective, “push back professionally.”

(10)  Requirement weaknesses: (a) 5.5.2 Management Representative, must have unrestricted access to top management personnel, (b) 7.5.1.1 Product and/or process re-verification, and (c) Sampling inspection-need method defined for critical products.

Have any AS9100C audit “Lessons Learned” you would like to share with us and our readers?  Please email us and we will share them in our June Newsletter.  As always, we will not print the name of the submitting individual and/or company.     

Last month we informed our readers about the 25th anniversary of the ISO 9001 standard.  Now, we are celebrating the same silver anniversary of the Baldrige Performance Excellence Program!

As the Baldrige Performance Excellence Program celebrates its 25th anniversary, it looks forward to continuing its journey to performance excellence in partnership with its Enterprise partners and its international network of Baldrige Criteria users and supporters, including

• the Baldrige Board of Examiners, a volunteer workforce of more than 500 members per year (more than 6,600 trained at the national level since 1987 and 2,397 trained by state programs in 2011 alone), who contribute the equivalent of more than $8 million in services each year
• an informal network of private consultants, who use the Baldrige Criteria to help their client organizations improve

• Baldrige-Award-winning organizations, who share role-model practices and strategies nationally and internationally

• thousands of other organizations that rely on the Baldrige model and framework as an improvement methodology, management model, and/or certification/accreditation standard

Ways that Baldrige Adds Value

1. Jobs Created
2. Lives saved
3. Increased sales, profits, and market share
4. Rising reading and mathematics proficiency
5. Benefit-to-cost ratio of 820-1. 

On April 15, 2012, U.S. Commerce Department Secretary John Bryson presented the 2011 U.S. organizations with the Malcolm Baldrige National Quality Award, the nation’s highest honor for organizational innovation and performance excellence.

The winners include:

• Concordia Publishing, St. Louis, Missouri (nonprofit)
• Henry Ford Health System, Detroit, Michigan (health care)
• Schneck Medical Center, Seymour, Indiana (health care)
•  Southcentral Foundation, Anchorage, Alaska (health care)

It’s obvious that health care organizations are making considerable progress with quality improvement and being recognized for their success.  Congratulations!

The Baldrige Award and the Baldrige Performance Excellence Program are managed by the Commerce Department’s National Institute of Standards and Technology (NIST) in conjunction with the private sector. For more information, http://www.nist.gov/baldrige. 

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

Organizations understand the importance of measuring and tracking quality, particularly in product manufacturing. However, applying rigorous quality measurement on an enterprise wide scale, beyond manufacturing and service levels, is relatively new. Nonetheless, some organizations have made strides toward establishing quality measurement programs and systems that serve the entire organization and its customers.

These types of organizations realize that creating innovative ways to measure and improve the quality of all processes benefits the business just as much as product and service innovations. Plus, improvements in how enterprise quality is measured affect the efficiency and effectiveness of an organization for years to come.

In 2011, the American Productivity and Quality Center (APQC), one of the world’s leading proponents of knowledge management, benchmarking, and best practices business research, set out to learn how organizations are applying quality principles enterprise wide in its best practices study, Using Enterprise Quality Measurement to Drive Business Value.

After a series of conversations with organizations already leveraging effective quality measurement practices and with others in search of those practices, the study team identified eight imperatives for an enterprise quality function. Without these practices in place, organizations typically struggle to arrive at any defined and replicable way to increase quality throughout the business.

The enterprise quality function imperatives are:

1. Align enterprise quality with strategic goals and initiatives.
2. Establish structures and resources to get the desired results.
3. Create supporting policies, procedures, and tools-not mandates.
4. Select, define, and standardize quality measures across the enterprise.
5. Allow business unit leaders to establish the performance targets for enterprise quality measures.
6. Report enterprise measures at least quarterly.
7. Design quality measures to focus on value-added quality activities and core strategic objectives.
8. Use measures to promote a culture of quality.

The study identified specific practices that enable organizations to achieve each imperative. It uncovered both the solid, foundational practices that most organizations are using to measure quality and the emerging practices that a few organizations are just starting to employ.

From the organizations in this study, business leaders can learn valuable insights and strategies for implementing systems, intranet, collaborative sites, assessment tools, scorecards, and more that can bring an enterprise together with a vision for quality.

To download a free copy of the report, visit APQC’s website.

Want to know how to increase productivity while reducing environmental impact? A new ISO standard does just that, by helping business cut costs linked to waste and emissions and enhancing their environmental performance.

The standard, ISO 14051:2011, Environmental management – Material flow cost accounting – General framework, assists organizations to better understand the environmental and financial consequences of their material and energy use practices, so that they can identify opportunities for improvement.

ISO 14051:2011 establishes a management information system approach called Material Flow Cost Accounting (MFCA), which can be used to trace and quantify material input and output flows and stocks within an organization. The system helps identify material and energy use practices, and understand these in costs and physical terms. The information can then be applied to reduce losses and increase gains.

Prof. Katsuhiko Kokubu, Convenor of the working group that developed the standard says, “Many organizations are unaware of the full extent of the cost of their material losses because this data is often difficult to extract from conventional information, accounting and environmental management systems. MFCA produces such precise and clear data that it can motivate managers to enhance material productivity and significantly reduce unnecessary waste far more effectively than through conventional means.”

MFCA is applicable to all industries that use materials and energy, including extractive, manufacturing, service and other industries. It can be implemented by organizations of any type and scale, with or without environmental management systems in place, in emerging economies as well as in industrialized countries.

MFCA is one of the major tools of environmental management accounting and is primarily designed for use within a single facility or organization. However, MFCA can be extended to multiple organizations within a supply chain, to help them develop and integrated approach to more efficient use of materials and energy.

To purchase the ISO 14051: 2011, Environmental management – Material flow cost accounting – General framework go to the

ANSI Standards Store.

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

If your company does not have a new employee orientation program, should it?  Yes, employee orientation has proven to be a critical element with making new employees comfortable and in retaining employees. Let’s take a look at some key reasons for orientation which are:

1. Shorten the time to get employees up to speed.
2. Lessen the anxiety when entering a new situation.
3. Reduce employee turnover with tools to succeed.
4. Convey job expectations and positive attitudes.

5.  Introduction to fellow coworkers.

An effective orientation program can make a significant difference in how quickly a new employee becomes oriented and becomes highly productive.

As part of new employee orientation, you should want to answer these quality related questions for them:

• Why are quality products and services so important?
• Why are we certified to this quality standard?
• What is my role in the quality management system?

Also, explain what is process related and how to perform:

• What are the key performance measures for my area?
• What are my required inputs and who provides them?
• What are my outputs and how do I measure effectiveness?
• What documents will be used and where are they located?
• What records are created and what to do with them?
• What are my required procedures and work instructions?
• Who do you see if a problem arises?

As a good quality professional, you should also be documenting training and ensuring a method of training effectiveness is applied. It is very important to convey your organizations commitment to quality, improvement, and continual process learning.

ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) have just published a new, improved guide to help standards writers address safety aspects in medical device standards even more thoroughly.

ISO/IEC Guide 63:2012, Guide to the development and inclusion of safety aspects in International Standards for medical devices, improves on and replaces a 1999 edition. Notably, it responds to the risk-based framework set out in ISO 14971: 2007,Medical devices – Application of risk management to medical devices.

ISO/IEC Guide 63 is designed to improve the interface between the standards-developing committees and the stakeholders they serve, as well as to make the optimal use of resources by only developing medical device safety standards for which there is a clear market requirement.

Alfred M. Dolan, Convenor of the team that updated the guidelines, described the benefits which the new guide is expected to bring to users and the improvements made compared to the 1999 edition it replaces:

“ISO/IEC Guide 63:2012 identifies common elements of all medical device safety standards and recommends a specific logical order to address these within a risk management framework as specified in ISO 14971. It provides a very helpful context in developing consistent standards.

“Compared to the 1999 version, the new guide accentuates the concept of risk and emphasizes the need to consider the relationship between hazards and the associated harms which may result. The resultant risk is what standards need to control through establishing technical or process requirements in those standards.”

ISO/IEC Guide 63 was prepared jointly by ISO/TC 210, Quality management and corresponding general aspects for medical devices, and IEC/SC 62A, Common aspects of electrical equipment used in medical practice, in a Joint Working Group, Application of risk management to medical devices.

Purchase ISO/IEC Guide 63 at the ANSI Standards Store.

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

During the years 2007 through 2010, there were 322 applications for the Malcolm Baldrige National Quality Award. These 322 applications were from 273 firms and organizations; the 49 additional applications were repeat applications from some of the 273 firms and organizations. The 273 firms and organizations that applied for the Award from 2007 through 2010 were asked by the Program Office to participate in a study of the benefits they received through the Award application process.

Specifically, each firm or organization was asked to complete a Web-based survey instrument. A total of 45 firms and organizations responded to the survey request-a response rate of 16.5%-and the results from an evaluation analysis based on those responses are discussed in this report.

Using a counterfactual evaluation method, three categories of social benefits have been quantified from the responses of 45 Award applicants to a Web-based survey.  These categories
are:

• the counterfactual cost savings of the applicants because it was not necessary for them to incur the investment costs to achieve on their own the same level of benefits from their performance excellence strategies as they realized from the availability of the publicly funded Baldrige Performance Excellence Program,
• the gains to consumers from greater satisfaction from higher quality products because the Baldrige Criteria were available and used,
• the gains to the economy from saving scarce resources (because successful performance excellence strategies not only enable higher quality products or services but also lower the costs of providing them) because the Baldrige Criteria were available and used.

The benefit-to-cost ratio of 820-to-1-using only the benefits for the surveyed group of applicants for the National Quality Award since 2006 but using all of the social costs of the Baldrige Program-certainly supports the belief that the Baldrige Program creates great value for the U.S. economy.

The Baldrige Performance Excellence Program, with the imprimatur of national leadership and a prominent national award presented by the President, creates great value that could not be
replicated by private sector actions alone.

The entire report is available in PDF at the NIST website.

The ISO 19011:2011 audit guidance standard has revised audit definitions, expanded related notes, and added new definitions. Some examples of these changes are described below.

The definition of audit: a systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which the audit criteria are fulfilled. Its revised note clarifies that the purpose of an internal audit may be to confirm the effectiveness of the management system or to obtain information for the improvement of the management system. The note adds that in a small organization, independence can be shown by freedom from responsibility for the activity being audited or freedom from bias and conflict of interest.

The definition of audit findings: the results of the evaluation of the collected audit evidence against audit criteria. A note states audit findings indicate conformity or nonconformity. A new note under audit findings clarifies that findings can lead to the identification of opportunities for improvement or recording good practices. Another new note says if the audit criteria are selected from legal or other requirements, the audit finding is termed compliance or non-compliance (instead of conformity or nonconformity).

The definition of audit client: the organization or person requesting an audit. Its note states that in the case of an internal audit, the audit client can also be the auditee or the person managing the audit program. The note also says requests for external audit can come from sources such as regulators, contracting parties, or potential clients.

The definition of competence: the ability to apply knowledge and skills to achieve intended results. The related note states that ability implies the appropriate application of personal behavior during the audit process.

The new definition for guide: a person appointed by the auditee to assist the audit team. The new definition for observer is: a person who accompanies the audit team but does not audit. Its notes add that an observer is not a part of the audit team and does not influence or interfere with the conduct of the audit. It says an observer can be from the auditee, a regulator, or other interested party who witnesses the audit.

The new definition for management system: a system to establish policy and objectives and to achieve those objectives. The related note states a management system of an organization can include different management systems, such as a quality management system, a financial management system, or an environmental management system.

Purchase ISO 9001:2011 Guidelines for auditing management systems at the ANSI Standards Store.

Our newsletters provide information on business management systems ISO 9001, AS9100 Aviation, Space and Defense, ISO/TS 16949 Automotive, ISO 27001 Information Security, ISO 13485 Medical Devices, ISO 14001 Environmental, and others.  This includes performance improvement methods such as Six Sigma, Lean Enterprise, and other topics of interest to our readers.

If you have any questions regarding the content or have a topic of interest for a future newsletter, please let us know.

Celebrating our 10th Year (2002-2012) Improving Performance!

We are very proud in celebrating our 10th anniversary of business improving operational and quality management systems performance.  It has been an extremely rewarding experience for us and we look forward to this New Year and Beyond.  Our sincere thanks to all our clients and newsletter readers.

While 66 percent of manufacturers expect to experience revenue growth in 2012, many say the recovering economy will remain a major hurdle to operations, according to a recent ASQ survey.

Nearly 1,600 manufacturing professionals from around the world responded to ASQ’s 2012 Manufacturing Outlook Survey, which was conducted online from Oct. 17 through Nov. 4. Respondents represent the aerospace, automotive, food, medical device, pharmaceutical and utility industries, among others.

According to the survey results, more than 70 percent of respondents say they experienced revenue growth in 2011. In ASQ’s 2011 Manufacturing Outlook Survey conducted in late 2010, 67 percent had hoped to experience revenue growth in 2011.

Despite the outlook regarding revenue, manufacturers continue to be wary of the global economy, citing the housing market and fears of a double-dip recession.

In addition to fears of the world economy, manufacturers say the lack of a qualified workforce is inhibiting their ability to grow. According to the survey results, 44 percent of respondents say finding qualified applicants is the biggest hurdle to filling vacant positions, while 27 percent say budget is a biggest hurdle to filling open positions. Twenty-three percent claim time-and the lack thereof-is the biggest hiring hurdle.

Retiring employees pose minimal effect.

Survey results show few manufacturers think their company will be adversely affected by retirements in 2012. On a scale of one to 10, where one is “very unlikely” and 10 is “very likely,” nearly 68 percent of respondents said retirements were “unlikely” to affect their business, including 26 percent who said retirements were “very unlikely” to affect the organization. Only 9 percent said retirements were “very likely” to affect the business.

“While many manufacturers are showing improvement and experiencing revenue growth, there remains clear hurdles facing these businesses,” said ASQ CEO Paul Borawski. “Even though companies say retiring baby boomers aren’t adversely affecting their businesses, finding qualified employees is still a concern-one that can affect businesses in this global economy-as retiring employees often leave with a wealth of knowledge not easily replaced.”

Beginning with the first publication of ISO 9000 in 1987, the impact of ISO on organizational practices and world trade has been tremendous. The development of management system approaches to many specific sectors has happened as well. Some of these you may not be aware of include:

ISO 10002:2004 Quality management – Customer Satisfaction – Guidelines for complaints handling in organizations.  ISO 10002 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement.

ISO 10003:2007 Quality Management – Customer Satisfaction Guidelines for Dispute Resolution External to Organizations.  ISO 10003 provides guidance for an organization to plan, design, develop, operate, maintain, and improve an effective and efficient dispute-resolution process. It is applicable to complaints relating to the organization’s products intended for, or required by, customers, the complaints-handling process, or dispute-resolution process

ISO/TS 10004:2010 Quality management – Customer satisfaction – Guidelines for monitoring and measuring.  ISO/TS 10004 provides guidance in defining and implementing processes to monitor and measure customer satisfaction. It is intended for use by organizations regardless of type, size, or product provided.

ISO 50001:2011 Energy Management (planned).  ISO 50001 will help organizations to improve their energy performance, increase energy efficiency, and reduce climate change impacts. It will establish a framework for industrial plants, commercial facilities or entire organizations to manage energy.

ISO 22000:2005 Food safety management systems. ISO 22000 specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

IWA 1:2005 Health Care quality management systems — Guidelines for process improvements in health service organizations.  IWA 1 provides additional guidance for any health service organization involved in the management, delivery, or administration of health service products or services, including training and/or research, in the life continuum process for human beings, regardless of type, size and the product or service provided.

ISO 31000:2009 Risk management.  ISO 31000 provides principles and generic guidelines on risk management. The standard can be applied to any type of risk, whether having positive or negative consequences.

ISO 20000-1:2011 Service management system requirements.  ISO 20000-1 is a service management system (SMS) standard. It specifies requirements for the service provider to plan, establish, implement, operate, monitor, review, maintain, and improve an SMS.

ISO has developed over 18,500 International Standards on a variety of subjects and some 1,100 new ISO standards are published every year. The full range of technical fields can be seen from the listing International Standards. Users can browse that listing to find bibliographic information on each standard and, in many cases, a brief abstract.

Click here to browse all ISO Standards.